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Efficacy and Safety of Grazax in Children

A

ALK-Abelló

Status and phase

Completed
Phase 3

Conditions

Allergy

Treatments

Biological: Grazax-R
Biological: Grazax Placebo

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

The purpose of this study is to investigate if immunotherapy with Grazax is safe and reduces the hayfever symptoms and the use of symptom relieving medications in children during the grass pollen season

Enrollment

253 patients

Sex

All

Ages

5 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Boys and girls 5-16 years of age
  • A clinical history of grass pollen induced hayfever
  • Positive Skin Prick Test to Phleum pratense
  • Positive specific IgE against Phleum pratense

Exclusion criteria

  • History of seasonal hayfever symptoms (and/or asthma) caused by another allergen than Phleum pratense during or overlapping the grass pollen season
  • History of perennial hayfever (and/or asthma) that needs medication due to an allergen to which the child is regularly exposed
  • History of severe asthma
  • Current severe atopic dermatitis

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

253 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
Grazax treatment
Treatment:
Biological: Grazax-R
2
Placebo Comparator group
Description:
Grazax Placebo
Treatment:
Biological: Grazax Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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